Cardiac surgeons' concerns, perceptions, and responses during the COVID-19 pandemic.

BACKGROUND: The coronavirus disease 2019 (COVID-19) pandemic has had an unprecedented impact on health care and cardiac surgery. We report cardiac surgeons' concerns, perceptions, and responses during the COVID-19 pandemic. METHODS: A detailed survey was sent to recruit participating adult cardiac surgery centers in North America. Data regarding cardiac surgeons' perceptions and changes in practice were analyzed. RESULTS: Our study comprises 67 institutions with diverse geographic distribution across North America. Nurses were most likely to be redeployed (88%), followed by advanced care practitioners (69%), trainees (28%), and surgeons (25%). Examining surgeon concerns in regard to COVID-19, they were most worried with exposing their family to COVID-19 (81%), followed by contracting COVID-19 (68%), running out of personal protective equipment (PPE) (28%), and hospital resources (28%). In terms of PPE conservation strategies among users of N95 respirators, nearly half were recycling via decontamination with ultraviolet light (49%), followed by sterilization with heat (13%) and at home or with other modalities (13%). Reuse of N95 respirators for 1 day (22%), 1 week (21%) or 1 month (6%) was reported. There were differences in adoption of methods to conserve N95 respirators based on institutional pandemic phase and COVID-19 burden, with higher COVID-19 burden institutions more likely to resort to PPE conservation strategies. CONCLUSIONS: The present study demonstrates the impact of COVID-19 on North American cardiac surgeons. Our study should stimulate further discussions to identify optimal solutions to improve workforce preparedness for subsequent surges, as well as facilitate the navigation of future healthcare crises.

An observational study to evaluate 2 target times for elective coronary bypass surgery.

BACKGROUND: Guidelines for timing of elective bypass surgery were established by expert opinion; yet, there is little evidence to support the recommended target times. OBJECTIVES: To estimate the effect of timing of the procedure on in-hospital mortality by comparing groups of patients that differ in the duration of time between decision to operate and performed procedure. RESEARCH DESIGN: We used a population-based registry to identify patients who underwent surgical coronary revascularization and their hospital discharge summaries to identify in-hospital death. SUBJECTS: We studied 9593 patients who underwent surgical revascularization between 1992 and 2006 after registration on a wait list for first-time isolated coronary artery bypass grafting on an elective basis. MEASURES: The outcome was postoperative in-hospital death. The study variable was the timing of surgery, categorized as short, prolonged, and excessive delays according to the guidelines. METHODS: The probability of in-hospital death in relation to timing of surgery was modeled by logistic regression that included a precalculated risk score for in-hospital death, with weighting observations by inverse propensity scores for the 3 surgery timing groups. RESULTS: In-hospital death among patients with short delays was one third as likely as among those with excessive delays: adjusted odds ratio=0.32 (95% confidence interval 0.20-0.51). The protective effect was smaller and not significant for patients with prolonged delays; odds ratio=0.78 (95% confidence interval, 0.38-1.63). CONCLUSIONS: Our findings suggest a survival benefit from performing elective surgical revascularization within the time frame recommended by the stricter of the 2 guidelines. Our results have implications for health systems that provide universal coverage and that budget the annual number of procedures.

Evaluation of supply-side initiatives to improve access to coronary bypass surgery.

BACKGROUND: Guided by the evidence that delaying coronary revascularization may lead to symptom worsening and poorer clinical outcomes, expansion in cardiac surgery capacity has been recommended in Canada. Provincial governments started providing one-time and recurring increases in budgets for additional open heart surgeries to reduce waiting times. We sought to determine whether the year of decision to proceed with non-emergency coronary bypass surgery had an effect on time to surgery. METHODS: Using records from a population-based registry, we studied times between decision to operate and the procedure itself. We estimated changes in the length of time that patients had to wait for non-emergency operation over 14 calendar periods that included several years when supplementary funding was available. We studied waiting times separately for patients who access surgery through a wait list and through direct admission. RESULTS: During two periods when supplementary funding was available, 1998-1999 and 2004-2005, the weekly rate of undergoing surgery from a wait list was, respectively, 50% and 90% higher than in 1996-1997, the period with the longest waiting times. We also observed a reduction in the difference between 90th and 50th percentiles of the waiting-time distributions. Forty percent of patients in the 1998, 1999, 2004 and 2005 cohorts (years when supplementary funding was provided) underwent surgery within 16 to 20 weeks following the median waiting time, while it took between 27 and 37 weeks for the cohorts registered in the years when supplementary funding was not available. Times between decision and surgery were shorter for direct admissions than for wait-listed patients. Among patients who were directly admitted to hospital, time between decision and surgery was longest in 1992-1993 and then has been steadily decreasing through the late nineties. The rate of surgery among these patients was the highest in 1998-1999, and has not changed afterwards, even for years when supplementary funding was provided. CONCLUSIONS: Waiting times for non-emergency coronary bypass surgery shortened after supplementary funding was granted to increase volume of cardiac surgical care in a health system with publicly-funded universal coverage for the procedure. The effect of the supplementary funding was not uniform for patients that access the services through wait lists and through direct admission.

Differences in myocardial PTEN expression and Akt signalling in type 2 diabetic and nondiabetic patients undergoing coronary bypass surgery.

OBJECTIVE: Patients with diabetes experience increased cardiovascular complications after cardiac surgery. Hyperglycaemia predicts increased mortality after myocardial infarction and may influence cardiovascular risk in humans. Impaired prosurvival phosphatase and tensin homologue on chromosome 10 (PTEN)-Akt signalling could be an important feature of the diabetic heart rendering it resistant to preconditioning. This study was designed to evaluate for differences and relationships of myocardial PTEN-Akt-related signalling and baseline glycaemic control marker in type 2 diabetic and nondiabetic patients undergoing coronary artery bypass surgery. METHODS: Right atrial biopsies and coronary sinus blood were obtained from 18 type 2 diabetic and 18 nondiabetic patients intraoperatively. Expression and phosphorylation of Akt, endothelial nitric oxide synthase (eNOS), Bcl-2 and PTEN were evaluated by Western blot. Plasma 15-F(2t) -isoprostane concentrations were evaluated by liquid chromatography-mass spectrometry. RESULTS: PTEN expression and 15-F(2t) -isoprostane concentrations were significantly higher in diabetic patients. Increased fasting blood glucose levels correlated with increased coronary sinus plasma 15-F(2t) -isoprostane concentrations. Increased cardiac 15-F(2t) -isoprostane generation was highly correlated with myocardial PTEN expression. Bcl-2 expression and eNOS phosphorylation were significantly lower in diabetic compared with nondiabetic patients. Akt phosphorylation tended to be lower in diabetic patients; however, this tendency failed to reach statistical significance. CONCLUSION: The current results suggest that prosurvival PTEN-Akt signalling is impaired in the diseased diabetic myocardium. Hyperglycaemia and increased oxidative stress may contribute to this phenomenon. These findings strengthen the understanding of the underlying biologic mechanisms of cardiac injury in diabetic patients, which could facilitate development of new treatments to prevent cardiovascular complications in this high-risk population.

Considerations for prostheses choice in multiple valve surgery.

OBJECTIVES: The prosthesis type for multiple valve surgery (replacement of two or more diseased native or prosthetic valves, replacement of two diseased valves with repair/reconstruction of a third, or replacement of a single diseased valve with repair/reconstruction of a second valve) remains inadequately evaluated. The clinical performance of multiple valve surgery with bioprostheses (BP) and mechanical prostheses (MP) was assessed to compare patient survival and composites of valve-related complications. METHODS: Between 1975 and 2000, 1245 patients had multiple valve surgery (BP 785, mean age 62.0 ± 14.7 years; and MP 460, mean age 56.9 ± 12.9 years). There were 1712 procedures performed [BP 969(56.6%) and MP 743(43.4%). Concomitant coronary artery bypass (conCABG) was BP 206(21.3%) and MP 105(14.1%) (p = 0.0002). The cumulative follow-up was BP 5131 years and MP 3364 years. Independent predictors were determined for mortality, valve-related complications and composites of complications. RESULTS: Unadjusted patient survival at 12 years was BP 52.1 ± 2.1% and MP 54.8 ± 4.6% (p = 0.1127), while the age adjusted survival was BP 48.7 ± 2.3% and MP 54.4 ± 5.0%. The predictors of overall mortality were age [Hazard Ratio (HR) 1.051, p < 0.0001], previous valve (HR 1.366, p = 0.028) and conCABG (HR 1.27, p = 0.021). The actual freedom from valve-related mortality at 12 years was BP 85.6 ± 1.6% and MP 91.0 ± 1.6% (actuarial p = 0.0167). The predictors of valve-related mortality were valve type (BP > MP) (2.61, p = 0.001), age (HR 1.032, p = 0.0005) and previous valve (HR 12.61, p < 0.0001). The actual freedom from valve-related reoperation at 12 years was BP 60.8 ± 1.9% and MP85.6 ± 2.1% (actuarial p < 0.001). The predictors of valve-related reoperation were valve type (MP > BP) (HR 0.32, p < 0.0001), age (HR 0.99, p = 0.0001) and previous valve (HR 1.38, p = 0.008) CONCLUSIONS: Overall survival (age adjusted) is differentiated by valve type over 10 and 12 years and valve-related mortality and valve-related reoperation favours the use of mechanical prostheses, overall for multiple valve surgery.

Proposed percutaneous aortic valve prosthesis made of cryogel.

Transcatheter heart valves are promising for high-risk patients. Generally, their leaflets are made of pericardium stented in a Nitinol basket. Despite their relative success, they are associated with significant complications such as valve migration, implantation risks, stroke, coronary obstruction, myocardial infraction, acute kidney injury (which all are due to the release of detached solid calcific pieces in to the blood stream) and expected issues existing with tissue valves such as leaflet calcification. This study is an attempt to fabricate the first ever polymeric percutaneous valves made of cryogel following the geometry and mechanical properties of porcine aortic valve to address some of the above-mentioned shortcomings. A novel, one-piece, tricuspid percutaneous valve, consisting of leaflets made entirely from the hydrogel, polyvinyl alcohol cryogel reinforced by bacterial cellulose natural nanocomposite, attached to a Nitinol basket was developed and demonstrated. Following the natural geometry of the valve, a novel approach was applied based on the revolution about an axis of a hyperboloid shape. The geometry was modified based on avoiding sharp warpage of leaflets and removal of the central opening orifice area of the valve when valve is fully closed using the finite element analysis. The modified geometry was replaced by a cloud of (control) points and was essentially converted to Bezier surfaces for further adjustment. A cavity mold was then designed and fabricated to form the valve. The fabricated valve was sewn into the Nitinol basket which is covered by Dacron cloth. The models presented in this study merit further development and revisions for both aortic and mitral positions.

Delay in admission for elective coronary-artery bypass grafting is associated with increased in-hospital mortality.

BACKGROUND: Many health care systems now use priority wait lists for scheduling elective coronary artery bypass grafting (CABG) surgery, but there have not yet been any direct estimates of reductions in in-hospital mortality rate afforded by ensuring that the operation is performed within recommended time periods. METHODS: We used a population-based registry to identify patients with established coronary artery disease who underwent isolated CABG in British Columbia, Canada. We studied whether postoperative survival during hospital admission for CABG differed significantly among patients who waited for surgery longer than the recommended time, 6 weeks for patients needing semi-urgent surgery and 12 weeks for those needing non-urgent surgery. RESULTS: Among 7316 patients who underwent CABG, 97 died during the same hospital admission, for a province-wide death rate at discharge of 1.3%. The observed proportion of patients who died during the same admission was 1.0% (27 deaths among 2675 patients) for patients treated within the recommended time and 1.5% (70 among 4641) for whom CABG was delayed. After adjustment for age, sex, anatomy, comorbidity, calendar period, hospital, and mode of admission, patients with early CABG were only 2/3 as likely as those for whom CABG was delayed to experience in-hospital death (odds ratio 0.61; 95% confidence interval [CI] 0.39 to 0.96). There was a linear trend of 5% increase in the odds of in-hospital death for every additional month of delay before surgery, adjusted OR = 1.05 (95% CI 1.00 to 1.11). CONCLUSION: We found a significant survival benefit from performing surgical revascularization within the time deemed acceptable to consultant surgeons for patients requiring the treatment on a semi-urgent or non-urgent basis.

Long-Term Outcomes of the Mosaic Bioprosthesis.

BACKGROUND: The Mosaic bioprosthesis is a third-generation stented porcine bioprosthesis. This study was performed to evaluate long-term survival and durability associated with this device. METHODS: A total of 1,029 patients (797 aortic valve replacements, 232 mitral valve replacements) previously enrolled at 6 centers as part of the original regulatory study were included. We evaluated freedom from death, valve-related reoperation, and explant due to structural valve deterioration (SVD), and compared these outcomes by age (<60 and ≥60 years) at the time of implant. RESULTS: Cumulative follow-up was 7021.2 patient-years in the aortic cohort and 1969.5 patient-years in the mitral cohort. Mean age was 69.5 ± 8.6 and 67.9 ± 10.5 years; 66% and 48% were male, respectively. In the aortic cohort at 17 years, freedom from death was 54.0% in patients younger than 60 years and 24.0% in patients aged 60 years and older (p < 0.01); freedom from reoperation was 36.4% and 81.2%, respectively (p < 0.01); and freedom from explant due to SVD was 47.5% and 89.1% (p < 0.01). At 16 years in the mitral cohort, freedom from death was 67.6% and 20.6% (p < 0.01); freedom from reoperation was 51.3% versus 77.9% (p = 0.04); and freedom from explant due to SVD was 65.2% versus 83.8% (p = 0.23). CONCLUSIONS: This study demonstrates acceptable long-term rates of death, reoperation, and explant due to SVD with the Mosaic bioprosthesis implanted in either the aortic or mitral position. Freedom from explant due to SVD was lower in patients younger than 60 years in the aortic cohort at 17 years, but it was not significantly different between patients younger than 60 years or 60 years and older in the mitral cohort at 16 years.

Prediction and risk stratification of survival in accidental hypothermia requiring extracorporeal life support: An individual patient data meta-analysis.

BACKGROUND: Extra-corporeal life support (ECLS) is a life-saving intervention for patients with hypothermia induced cardiac arrest or severe cardiovascular instability. However, its application is highly variable due to a paucity of data in the literature to guide practice. Current guidelines and recommendations are based on expert opinion, single case reports, and small case series. Combining all of the published data in a patient-level analysis can provide a robust assessment of the influence of patient characteristics on survival with ECLS. OBJECTIVE: To develop a prediction model of survival with good neurologic outcome for accidental hypothermia treated with ECLS. METHODS: Electronic searches of PubMed, EMBASE, CINAHL were conducted with a hand search of reference lists and major surgical and critical care conference abstracts. Studies had to report the use of ECLS configured with a circuit, blood pump and oxygenator with an integrated heat exchanger. Randomized and observational studies were eligible for inclusion. Non-human, non-English and review manuscripts were deemed ineligible. Study authors were requested to submit patient level data when aggregate or incomplete individual patient data was provided in a study. Survival with good neurologic outcome was categorized for patients to last follow-up based on the reported scores on the Cerebral Performance Category (1 or 2), Glasgow Outcome Scale (4 or 5) and Pediatric Overall Performance Category (1 or 2). A one-stage, individual patient data meta-analysis was performed with a mixed-effects multi-level logistic regression model reporting odds ratio (OR) with a 95% confidence interval (CI). RESULTS: Data from 44 observational studies and 40 case reports (n = 658) were combined and analyzed to identify independent predictors of survival with good neurologic outcome. The survival rate with good neurologic outcome of the entire cohort was 40.3% (265 of 658). ECLS rewarming rate (OR: 0.93; 95% CI: 0.88, 0.98; p = .007), female gender (OR: 2.78; 95% CI: 1.69, 4.58; p < 0.001), asphyxiation (OR: 0.19; 95% CI: 0.11, 0.35; p < 0.001) and serum potassium (OR: 0.62; 95% CI: 0.53, 0.73; p < 0.001) were associated with survival with a good neurologic outcome. The logistic regression model demonstrated excellent discrimination (c-statistic: 0.849; 95% CI: 0.823, 0.875). CONCLUSIONS: The use of extracorporeal life support in the treatment of hypothermic cardiac arrest provides a favourable chance of survival with good neurologic outcome. When used in a weighted scoring system, asphyxiation, serum potassium and gender can help clinicians prognosticate the benefit of resuscitating hypothermic patients with ECLS.

Oval housing for the St. Jude Medical bileaflet mechanical heart valve.

The St. Jude Medical bileaflet mechanical heart valve was approved by the Food and Drug Administration in late 1970s. The basic idea for the design of the valve is simply two semicircular flat plates pivoting on hinges. The overall performance of St. Jude Medical valves such as blood flow being central, the leaflets opening completely, and the pressure drop across the valve being trivial is satisfactory. St. Jude Medical valves provide an improved hemodynamics compared to the other mechanical heart valve models; however, their non-physiological hemodynamics which may lead to red blood cells lysis and thrombogenicity still remains a major issue. In this study, we hypothesize that applying ovality to the housing might improve their hemodynamics significantly which is based on the fact that the native annulus is oval by nature. A quick but precise numerical model based on the finite strip method was developed by which the regurgitation flow volume and velocity of the proposed design were assessed in the closing phase. The results are satisfactory and an improved hemodynamics is observed. The proposed design can be considered for further numerical and experimental studies and shows promise and merits further development.

Long-term Outcomes of Multiple Arterial Coronary Artery Bypass Grafting: A Population-Based Study of Patients in British Columbia, Canada.

Importance: Although the long-term survival advantage of multiple arterial grafting (MAG) vs the standard use of left internal thoracic artery (LITA) supplemented by saphenous vein grafts (LITA+SVG) has been demonstrated in several observational studies, to our knowledge its safety and other long-term clinical benefits in a large, population-based cohort are unknown. Objective: To compare the safety and long-term outcomes of MAG vs LITA+SVG among overall and selected subgroups of patients. Design, Setting, and Participants: In this population-based observational study, we included 20 076 adult patients with triple-vessel or left-main disease who underwent primary isolated coronary artery bypass grafting (MAG, n = 5580; LITA+SVG, n = 14 496) in the province of British Columbia, Canada, from January 2000 to December 2014, with follow-up to December 2015. We performed propensity-score analyses by weighting and matching and multivariable Cox regression to minimize treatment selection bias. Exposures: Multiple arterial grafting or LITA+SVG. Main Outcomes and Measures: Mortality, repeated revascularization, myocardial infarction, heart failure, and stroke. Results: Of 5580 participants who underwent MAG, 586 (11%) were women and the mean (SD) age was 60 (8.7) years. Of 14 496 participants who underwent LITA+SVG, 2803 (19%) were women and the mean (SD) age was 68 (8.9) years. The median (interquartile range) follow-up time was 9.1 (5.1-12.6) years and 8.1 (4.5-11.7) years for the groups receiving MAG and LITA+SVG, respectively. Compared with LITA+SVG, MAG was associated with reduced mortality rates (hazard ratio [HR], 0.79; 95% CI, 0.72-0.87) and repeated revascularization rates (HR, 0.74; 95% CI, 0.66-0.84) in 15-year follow-up and reduced incidences of myocardial infarction (HR, 0.63; 95% CI, 0.47-0.85) and heart failure (HR, 0.79; 95% CI, 0.64-0.98) in 7-year follow-up. The long-term benefits were coherent by all 3 statistical methods and persisted among patient subgroups with diabetes, obesity, moderately impaired ejection fraction, chronic obstructive pulmonary disease, peripheral vascular disease, or renal disease. Multiple arterial grafting was not associated with increased morbidity or mortality rates at 30 days overall or within patient subgroups. Conclusions and Relevance: Compared with LITA+SVG, MAG is associated with reduced mortality, repeated revascularization, myocardial infarction, and heart failure among patients with multivessel disease who are undergoing coronary artery bypass grafting without increased mortality or other adverse events at 30 days. The long-term benefits consistently observed across multiple outcomes and subgroups support the consideration of MAG for a broader spectrum of patients who are undergoing coronary artery bypass grafting in routine practice.

Simulation of Anastomosis in Coronary Artery Bypass Surgery.

Developing cardiac surgical skills and experience takes years of practice. Cardiac trainees need to develop technical proficiency in order to enhance quality of care and patient safety. Simulation-based models are common resources for teaching procedural skills in both undergraduate and postgraduate medical education. Suitable and accessible educational platforms can play a progressively important role in the training process for young surgeons in the area of cardiac surgery. Coronary artery bypass graft (CABG) surgery consists of a wide range of pathologic anatomies and surgical techniques. In this paper we introduce a novel, synthetic, biomimetic platform that allows for the realistic practice of the CABG surgery. The prototype uses a polyvinyl alcohol hydrogel which has been designed to mimic the geometric properties of vasculature. The proposed models look and feel like human tissue and possess somewhat consistent mechanical properties. In this study, we apply the platform to simulate a case of autogenous saphenous vein bypass grafting of a patient. An autogenous saphenous vein graft is placed from the aorta to the left anterior descending coronary artery. The standard procedures of the coronary artery bypass surgery were successfully simulated. Using the proposed technology, other complicated surgeries such as end to end, side to end, and sequential anastomoses can be simulated such that these models lend themselves very well to various types of anastomoses.

Hemodynamic study of the elliptic St. Jude Medical valve: A computational study.

Despite successful implantation of St. Jude Medical bileaflet mechanical heart valves, red blood cell lysis and thrombogenic complications associated with these types of valves are yet to be addressed. In our previous study, we proposed an elliptic housing where 10% ovality was applied to the housing of St. Jude Medical valves. Our preliminary results suggested that the overall hemodynamic performance of St. Jude Medical valves improved in both the closing and opening phases. In this study, we evaluated the hemodynamics around the leaflets in the opening phase using a more sophisticated computational platform, computational fluid dynamics. Results suggested both lower shear stress and wall shear stress values and an overall improved hemodynamic performance in the proposed design. This improvement is characterized by lower values of shear stress and wall shear stress in the regions downstream of the leaflets, lower pressure drop across the valve and smaller recirculation zones in the sinuses areas. The proposed design may open a new chapter in the concept of design and hemodynamic improvement of the next generation of mechanical heart valves.

Effect of heart rate on the hemodynamics of bileaflet mechanical heart valves' prostheses (St. Jude Medical) in the aortic position and in the opening phase: A computational study.

To date, to the best of the authors' knowledge, in almost all of the studies performed around the hemodynamics of bileaflet mechanical heart valves, a heart rate of 70-72 beats/min has been considered. In fact, the heart rate of ~72 beats/min does not represent the entire normal physiological conditions under which the aortic or prosthetic valves function. The heart rates of 120 or 50 beats/min may lead to hemodynamic complications, such as plaque formation and/or thromboembolism in patients. In this study, the hemodynamic performance of the bileaflet mechanical heart valves in a wide range of normal and physiological heart rates, that is, 60-150 beats/min, was studied in the opening phase. The model considered in this study was a St. Jude Medical bileaflet mechanical heart valve with the inner diameter of 27 mm in the aortic position. The hemodynamics of the native valve and the St. Jude Medical valve were studied in a variety of heart rates in the opening phase and the results were carefully compared. The results indicate that peak values of the velocity profile downstream of the valve increase as heart rate increases, as well as the location of the maximum velocity changes with heart rate in the St. Jude Medical valve model. Also, the maximum values of shear stress and wall shear stresses downstream of the valve are proportional to heart rate in both models. Interestingly, the maximum shear stress and wall shear stress values in both models are in the same range when heart rate is <90 beats/min; however, these values significantly increase in the St. Jude Medical valve model when heart rate is >90 beats/min (up to ~40% growth compared to that of the native valve). The findings of this study may be of importance in the hemodynamic performance of bileaflet mechanical heart valves. They may also play an important role in design improvement of conventional prosthetic heart valves and the design of the next generation of prosthetic valves, such as percutaneous valves.

Outcome of mitral valve repair or replacement: a comparison by propensity score analysis.

BACKGROUND: There are no randomized trials comparing outcomes after mitral valve (MV) repair and replacement. Propensity scoring is a powerful tool that has the potential to reduce selection bias in nonrandomized studies. METHODS: From the BC Cardiac Registries, 2,060 patients presented for MV surgery, with or without CABG between 1991 and 2000. We then identified 322 MV repairs who were then matched by propensity score to an equal number of MV replacement patients. We compared survival and freedom from re-operation outcomes using Cox proportional hazards model analysis. Multivariable analysis was then used to compare outcomes in 358 MV repair patients with 352 MV replacement patients who had undergone chordal sparing surgery. RESULTS: The comparison groups generated using propensity scores were well balanced with respect to all collected baseline risk factors. Median follow-up time was 3.4 years. Patients undergoing MV repair had significantly improved survival (RR 0.46; 95% CI, 0.28 to 0.75) but a trend toward more re-operations (RR 2.11; 95% CI, 1.00 to 4.47) compared with patients undergoing replacement. Mitral valve repair patients still had better survival (RR 0.52; 95% CI, 0.32 to 0.85) compared with MV replacement patients who had undergone chordal sparing surgery. CONCLUSIONS: We used propensity score methods to reduce selection bias in a population-based cohort of patients undergoing MV repair/replacement. Repair was associated with better survival, but a trend to increased re-operation.

Medtronic mosaic porcine bioprosthesis: investigational center experience to six years.

BACKGROUND AND AIM OF THE STUDY: The findings of this single-center experience with the Medtronic Mosaic porcine bioprosthesis were evaluated to determine the clinical performance of the valve. METHODS: Between 1994 and 2000, a total of 657 patients was implanted with the prosthesis. Aortic valve replacement (AVR) was performed in 415 patients (mean age 70.5+/-10.7 years; range: 26-89 years) and mitral valve replacement (MVR) in 242 patients (mean age 70.5+/-9.5 years; range: 19-86 years). Concomitant coronary artery bypass (CAB) was performed in 51.1% and 46.7% of AVR and MVR patients, respectively. The majority of patients were aged over 70 years (59.8% AVR, 58.7% MVR). RESULTS: Survival at six years was 73.0+/-2.4% after AVR, and 74.0+/-5% after MVR (p = NS). Actual freedom from valve-related mortality at six years was 98+/-1% for AVR and 96+/-1% for MVR; freedom from overall thromboembolism (TE) was 86+/-3% for AVR and 89+/-2% for MVR. After AVR, 42 thromboembolic events occurred in 39 patients (23 minor; 14 major; three reversible ischemic neurologic deficits (RIND); two thrombosis). After AVR, the late TE rate was 2.1% per pt-yr, and the major rate 0.6% per pt-yr (exclusive of thrombosis). The overall TE rate after AVR was 2.9% per pt-yr (major rate 1% per pt-yr). After MVR, 25 events occurred in 24 patients (10 minor; eight major; five RIND; two thrombosis). After MVR, the late TE rate was 2.6% per pt-yr, and the major rate 0.7% per pt-yr (exclusive of thrombosis). The overall TE rate after MVR was 3.5% per pt-yr (major rate 1.1% per pt-yr). There were four cases of structural valve deterioration (SVD) (two each after AVR and MVR). Reoperation was performed in three of four cases of thrombosis, and in two of four cases of SVD. CONCLUSION: The Medtronic Mosaic porcine bioprosthesis is safe and effective. The rate of SVD after six years was low, being zero in the aortic position of patients aged >60 years, and zero also in the mitral position of patients aged <60 years. The incidence of early and late thromboembolism was contributed to by the advanced age of the patient population.

Mitral valve reconstruction: experience related to early and late mortality and reoperation.

BACKGROUND AND AIM OF THE STUDY: The present authors' experience with mitral valve reconstruction was reviewed to determine the influence of anatomical and functional abnormalities on mortality and reoperation. METHODS: Between 1991 and 2001, a total of 397 patients (mean age 59.0 +/- 13.4 years) underwent mitral valve reconstruction at the authors' institution. Patients were grouped according to the Carpentier functional classification as follows: type I, n = 88 (mean age 57.4 years; range: 24-81 years); type II, n = 169 (mean age 59.8 years; range: 16-81 years); type IIIa, n = 44 (mean age 52.8 years; range: 22-78 years); type IIIb, n = 85 (mean age 65.1 years; range: 33-82 years); and congenital (C), n = 11 (mean age 36.2 years; range: 18-65 years). RESULTS: The total follow up was 1,485.8 patient-years (pt-yr). Early mortality was: type I, 3.4% (n = 3); type II, 0; type IIIa; 2.3% (n = 1); type IIIb, 9.4% (n = 8); and C, 0 (p = 0.0028, IIIb > II and C). The late mortality was: type I, 2.1%/pt-yr (n = 6); type II, 1.1%/pt-yr (n = 7); type IIIa, 1.8%/pt-yr (n = 4); type IIIb, 4.3%/pt-yr (n = 12); and C, 1.7%/pt-yr (n = 1) (p = 0.0035 IIIb > II). The overall survival at 10 years was 79.6 +/- 4.2% (p <0.001, II > IIIb; p = 0.029, I > IIIb; p = 0.046, II > I). The reoperations were: type I, 1.4%/pt-yr (n = 4); type II, 1.9%/pt-yr (n = 12); type IIIa, 0.9%/pt-yr (n = 2); type IIIb, 0.4%/pt-yr (n = 1); and C, 0 (p = 0.0435 II > IIIb). Among the 19 reoperations there were 17 replacements, one re-repair, and one annuloplasty. The failures were predominantly type II, posterior (n = 5) and anterior (n = 5), or a combination (n = 2). The overall freedom from reoperation was 92.0 +/- 2.2% (p = NS between groups). CONCLUSION: Mitral valve reconstruction can be performed in all four functional categories with generally satisfactory results, except possibly for functional ischemic disease. The results of surgery for degenerative disease afford the opportunity for early surgical management, if proven techniques are adhered to in order to minimize the risk of reoperation. The repair of ischemic disease due primarily to ventricular dysfunction is in a state of evolution.

A novel computational model for the hemodynamics of bileaflet mechanical valves in the opening phase.

A powerful alternative means to study the hemodynamics of bileaflet mechanical heart valves is the computational fluid dynamics method. It is well recognized that computational fluid dynamics allows reliable physiological blood flow simulation and measurements of flow parameters. To date, in almost all of the modeling studies on the hemodynamics of bileaflet mechanical heart valves, a velocity (mass flow)-based boundary condition and an axisymmetric geometry for the aortic root have been assigned, which, to some extent, are erroneous. Also, there have been contradictory reports of the profile of velocity in downstream of leaflets, that is, in some studies, it is suggested that the maximum blood velocity occurs in the lateral orifice, and in some other studies, it is postulated that the maximum velocities in the main and lateral orifices are identical. The reported values for the peak velocities range from 1 to 3 m/s, which highly depend on the model assumptions. The objective of this study is to demonstrate the importance of the exact anatomical model of the aortic root and the realistic boundary conditions in the hemodynamics of the bileaflet mechanical heart valves. The model considered in this study is based on the St Jude Medical valve in a novel modeling platform. Through a more realistic geometrical model for the aortic root and the St Jude Medical valve, we have developed a new set of boundary conditions in order to be used for the assessment of the hemodynamics of aortic bileaflet mechanical heart valves. The results of this study are significant for the design improvement of conventional bileaflet mechanical heart valves and for the design of the next generation of prosthetic valves.

Traumatic rupture of the thoracic aorta: third decade of experience.

BACKGROUND: Traumatic rupture of the thoracic aorta is a relatively common injury of deceleration accidents, usually high-speed motor vehicle accidents. Spinal cord injury has been a well-documented complication of surgical management. The use of nonheparinized partial bypass with a centrifugal pump was evaluated for protection against spinal cord injury and reduction of risk of associated injuries. METHODS: From 1989 to 1999, the third decade of the authors' experience, traumatic rupture was diagnosed in 58 patients (male 46 and female 12; mean age 39.9 years, range 17 to 85). Associated injuries were documented in 98.3% (57 patients). In all, 45 patients (77.6%) had the opportunity for definitive surgical management; 42 (93.3%) were managed with partial cardiopulmonary bypass, 35 without the use of heparin. Full cardiopulmonary bypass was utilized in 1 patient while 2 had repair without cardiopulmonary bypass support. Thirteen patients did not have the opportunity for definitive surgical management, 1 death on arrival, 8 (61.5%) suspected, and 4 (30.8%) diagnosed. RESULTS: There were 6 deaths in the surgical group, 5 in nonheparinized patients. The causes were intraoperative hypovolemia (2), anoxic brain death after intraoperative cardiac arrest (1), sepsis (1), and adult respiratory distress syndrome (1). The other was in the simple aortic cross-clamp group from intraoperative pulmonary compromise. There was one spinal cord injury, paraparesis in 1 of the 2 patients managed without bypass support. The total hospital stay ranged from 8 to 112 days, primarily owing to management of associated injuries. Of the 13 patients who did not have the opportunity for definitive surgical management, 5 had unsuccessful emergency thoracotomy and 3 survived the hospital course without surgery. Of the total population, the overall mortality was 27.6%, whereas the mortality of the potentially operable patients was 25.8%. Of the surgical group, the intraoperative mortality was 6.7% and 30-day mortality was 13.3%. CONCLUSIONS: Spinal cord injury was prevented by the use of partial cardiopulmonary bypass. Nonheparinized bypass was likely to be a contributory factor to lack of mortality directly related to associated injuries.

The mosaic valve clinical performance at seven years: results from a multicenter prospective clinical trial.

BACKGROUND AND AIM OF THE STUDY: The Mosaic valve is a third-generation stented porcine bioprosthesis built upon the historical durability of the Hancock II valve in an attempt to improve hemodynamic performance and durability. METHODS: This multicenter trial was prospective and non-randomized in design. Between February 1994 and October 1999, six centers following a common study protocol enrolled 797 patients (mean age 70 years: range: 21-88 years) who underwent aortic valve replacement (AVR), and 232 patients (mean age 68 years; range: 17-84 years) who underwent mitral valve replacement (MVR). The cumulative follow up was 3,442 patient-years (pt-yr) for AVR (mean 4.3 years; maximum 8 years), and 870 pt-yr for MVR (mean 3.7 years; maximum 7 years). Follow up was complete for 95% of AVR patients, and for 97% of MVR patients. RESULTS: The mean gradient and calculated effective orifice area average across all valve sizes remained stable at one, four and six years. Freedom from valve-related adverse events (mean +/- SE) at one, four and seven years after AVR were, respectively: Antithromboembolic-related hemorrhage (ARH) 97.0 +/- 0.6, 95.6 +/- 0.9, and 94.6 +/- 5.1%; primary hemolysis 100, 100, and 100%; and structural valve deterioration (SVD) 100, 100 and 100%. Freedom at one, four and seven years after MVR were: ARH 96.9 +/- 1.2, 95.6 +/- 2.0, and 95.6 +/- 7.6%; primary hemolysis 100, 100, and 100%; and SVD 100, 100, and 100%. CONCLUSION: These mid-term results demonstrate the clinical safety and excellent performance of the Mosaic valve. Continued follow up will determine if this new-design, third-generation bioprosthesis will provide increased durability.